Edwards Lifesciences LLC approved for sale of catheter aortic valve system product

On June 8, the State Drug Administration announced that it had recently approved the registration of the "Through catheter aortic valve system" of an innovative product produced by Edwards Lifesciences LLCthe product includes the catheter aortic valve, the catheter aortic valve delivery system, the catheter sac kit, the femoral cyatic catheter, the valve preset deviceThe valve is composed of cow heart wrap lobes, cobalt-chromium alloy flaps, and PET inner and outer skirtsPatients with severe calcified aortic aortic valve stenosis for treatments determined by the heart team, including cardiovascular surgeons (e.g., according to the American Thoracic Surgeons' (STS) scoring system to assess surgical risk of surgery by 8% or a 30-day mortality rate for surgerythe product uses balloon expansion technology, the flap can provide high radial support, low valve height to accommodate the surrounding anatomical structure, and minimize the risk of pacemaker implantation; The expected incidence of clinical application valve peripheral leakage is lowdrug regulatory authorities will strengthen post-marketing supervision of the product to protect the safety of patients.